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Gluten Free Diet in Hashimoto's Hypothyroidism

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 29, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 2 months later Aug 1, 2026 → Oct 1, 2026
See other at-risk trials from The Cleveland Clinic

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion pushed from Aug 1, 2026 to Oct 1, 2026
    • Interventions: Gluten Free Diet in Hashimoto's Hypothyroidism (Dietary Supplement) to Gluten Free Diet in Hashimoto's Hypothyroidism (Dietary Supplement)
    • Eligibility criteria expanded, about 11 words
  2. Minor Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised
    v4
  3. Notable Primary completion date: Feb 1, 2026 to Aug 1, 2026
    • Study completion date: Jun 30, 2026 to Dec 30, 2026
    v3
  4. Minor Primary completion date: Feb 2026 to Feb 1, 2026
    • Study completion date: Jun 2026 to Jun 30, 2026
    • Start date changed from estimate of Jul 2025 to Jul 15, 2025
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Hashimoto's thyroiditis is an autoimmune condition that reduces functioning of the thyroid gland and can lead to a substantial decline in quality of life for patients, with impacted patients often describing unremitting brain fog, fatigue/malaise and weight gain leading to difficulty functioning in their jobs and homes. It is the most common cause of hypothyroidism in the U.S. and affects up to 10% of the global population. The typical treatment for Hashimoto's is thyroid hormone replacement with medications such as levothyroxine. However, despite adequate treatment as defined by thyroid hormone levels within the reference range, up to 10% of patients will experience persisting symptoms which can dramatically impair quality of life. While various theories have been postulated for the residual symptoms, several studies indicate that they are related to the thyroid autoimmunity, specifically the autoantibodies that are made by the immune system in Hashimoto's thyroiditis in response to the thyroid (ie thyroid peroxidase \[TPO\], thyroglobulin \[Tg\] antibody \[AB\]) and the associated inflammation with the immune response. Removal of thyroid (ie total thyroidectomy) reduces levels of these thyroid antibodies and results in significant improvement in quality-of-life. However, thyroidectomy is an invasive procedure with potential for morbidity such as damage to the recurrent laryngeal (nerve that controls the vocal cords and thus speech), bleeding and infection, so there is interest in other more conservative modalities for lowering the inflammation and autoimmune burden in Hashimoto's thyroiditis. In an effort to identify a less invasive approach for reducing the levels of thyroid antibodies and inflammation, attention has moved to the intersection of Hashimoto's thyroiditis and the gut. Hashimoto's has a strong association with autoimmune disorders impacting the gastrointestinal tract, in particular celiac disease and non-celiac gluten sensitivity (NCGS). NCGS is a condition where there are intestinal and extra-intestinal symptoms associated the consumption of gluten but no presence of anti-tissue transglutaminase antibodies (anti-tTG) which define Celiac Disease. This connection between Hashimoto's thyroiditis and sensitivity to gluten appears to be not only genetic, as those with Celiac Disease/NCGS and Hashimoto's thyroiditis have common HLA haplotypes, but also at the level of the intestine with gut microbiome dysfunction.
Trial Details
NCT Number NCT07060118
Lead Sponsor The Cleveland Clinic
Conditions
(from sponsor)
Hypothyroidism, Hashimoto Disease
Related terms Hashimoto Disease, Hypothyroidism
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov